Legionella Pneumophila Antigen Rapid Test Cassette (Urine) is a rapid test for the qualitative detection of Legionella Pneumophila Antigen in urine.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Legionella Pneumophila Antigen Rapid Test Cassette (Urine) is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila antigen in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection (Legionnaires’ disease) caused by L.pneumophila in conjunction with culture and other methods.
【PRINCIPLE】
The Legionella Pneumophila Antigen Rapid Test Cassette (Urine) is a qualitative, membrane based immunoassay for the detection of L.pneumopila antigen in urine. The membrane is pre-coated with antibody to L.pneumopila on the test line region of the cassette. During testing, the urine specimen reacts with L.pneumopila antibody conjugated colloid gold. The mixture migrates upward on the membrane chromatographically by capillary action to react with L.pneumopila antibody on the membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.